MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011110

Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Skin Irritation (2076); Swelling (2091); Tissue Damage (2104)

Event Date 05/06/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges the patient suffers from pain, discomfort and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.In addition to what was previously alleged, pfs alleges swelling, drainage, large hematoma,yellow skin color, grinding and a cane for walking.After review of medical records for the mdr reportability, patient was revised to address failed right total hip arthroplasty due to metallosis, severe pain, dysfunction and failed recall stem implant.Revision notes reported of increased pain, dysfunction, peritrochanteric soft tissue mass and elevated metal lie.It was also indicated that there was an extensive scar tissue and changes in the soft tissues in the peritrochanteric tissues.It was also stated that there was a large grey metallosis, metal corrosion, extra bone in anterior-inferior recess and malpositioned liner.It was noted within the revision note that their was evidence of cup loosening.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ5 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7053985
• MDR Text Key: 92793242
• Report Number: 1818910-2017-29623
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: 10603295060062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: 157011110
• Device Lot Number: C3JBG1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 86